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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP compliant study conducted in compliance with OECD guideline 404 with minor deviation: no details on test animals and environmental conditions; no details on patch material; observations not followed until the reversibility of the effects (only 7 days)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
. There is no certificate of analysis of the test substance; no details on test animals and environmental conditions; no details on patch material; and observations are not followed until the reversibility of the effects (only 7 days).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Terpineol alpha
- Source: Givaudan-Roure

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
Test 1: 3
Test 2&3: 4
Details on study design:
SCORING SYSTEM: Draize scoring system
- tested in a multi-patch study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 h
Score:
2.44
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 h
Score:
2.17
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 h
Score:
2.58
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 h
Score:
1.92
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 h
Score:
2.08
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritant / corrosive response data:
Test 1: Two animals showed marked desquamation at the 7 day time interval. The other animal showed thickening and marked desquamation of the skin surface at the 7 day time interval.
Test 2: One animal showed slight desquamation at the 7 day time interval. The three other animals showed marked desquamation at the 7 day time interval.
Test 3: Two animals showed slight desquamation at the 7 day time interval. One animal showed slight desquamation at the 2, 3, and 7 day time interval. One animal showed marked desquamation at the 7 day time interval

Any other information on results incl. tables

 Test 1

 

1 hr

1 day

2 days

3 days

7 days

Mean (24, 48, 72 hrs)

Animal No. 1

Erythema

0

1

2

2

1

1.67

Oedema

1

2

2

2

1

2

Animal No. 2

 

Erythema

2

2

2

2

2

2

Oedema

2

3

2

2

1

2.33

Animal No. 3

 

Erythema

2

2

2

3

3

2.33

Oedema

2

3

3

3

3

3

 

Test 2

 

1 hr

1 day

2 days

3 days

7 days

Mean (24, 48, 72 hrs)

Animal No. 1

Erythema

2

2

2

2

2

2

Oedema

2

3

3

3

1

3

Animal No. 2

 

Erythema

2

2

3

3

2

2.67

Oedema

3

3

3

3

3

3

Animal No. 3

 

Erythema

2

2

2

2

2

2

Oedema

2

3

2

3

3

2.67

Animal No. 4

 

Erythema

1

2

2

2

1

2

Oedema

2

2

2

1

0

1.67

 

Test 3

 

1 hr

1 day

2 days

3 days

7 days

Mean (24, 48, 72 hrs)

Animal No. 1

Erythema

2

2

2

2

1

2

Oedema

2

3

3

2

0

2.67

Animal No. 2

 

Erythema

2

2

2

2

2

2

Oedema

2

2

2

2

2

2

Animal No. 3

 

Erythema

1

2

2

1

0

1.67

Oedema

0

1

1

0

0

0.67

Animal No. 4

 

Erythema

2

2

2

2

1

2

Oedema

1

3

3

3

1

3

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions the substance is considered to be irritating to the skin.
Executive summary:

In three primary dermal irritation studies performed according to OECD guideline 404 and in compliance with GLP, three or four albino rabbits were dermally exposed to 0.5 mL of undiluted alpha-Terpineol under a semi-occlusive patch for 4 hours to intact skin of the flank. Animals were then observed for 7 days. Irritation was scored by the method of Draize at 1, 24, 48 and 72 hours and 7 days after exposure. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals of the first test were 1.67, 2 and 2.33 for erythema score and 2, 2.33 and 3 for edema score. For the second test the mean individual scores were 2, 2.67, 2 and 2 for erythema score and 3, 3, 2.67 and 1.67 for edema score. For the third test the mean individual scores were 2, 2, 1.67 and 2 for erythema score and 2.67, 2, 0.67 and 3 for edema score. Under the test conditions the substance is considered to be irritating to the skin because the average oedema score exceeded 2 (DSD C&L) or 2.5 (CLP) and the effects were not fully reversible within the observation period of 7 days.